ISRCTN28058693已完成未知
Randomised controlled trial of home mechanical ventilation in hypercapnic chronic obstructive pulmonary disease patients post acute hypercapnic exacerbation
Guy's and St. Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 116 人开始时间: 2010年3月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Acute hypercapnic exacerbation of COPD at least 2 weeks previously
- •2. In patient admission with acute hypercapnic respiratory failure
- •3. Smoking greater than 20 pack year history
- •4. Forced expiratory volume in one second (FEV1) less than 50%
- •5. FEV1/forced vital capacity (FVC) less than 60%
- •6. Chronic hypercapnia (PaCO2 greater than 7 kPa)
- •7. Chronic hypoxia PaO2 less than 7.3 kPa or less than 8 kPa with secondary polycythaemia, pulmonary hypertension, peripheral oedema or significant nocturnal hypoxia (SpO2 less than 90% for greater than 30% sleep time)
- •8. Aged 18 years or older, either sex
排除标准
- •1. Unable to wean off NIV prior to discharge (persistent hypercapnic respiratory failure with pH less than 7.30)
- •2. Post extubation or decanulation
- •3. Body mass index (BMI) greater than 35 kg/m^2
- •4. Primary diagnosis of restrictive lung disease causing hypercapnia
- •5. Development of worsening hypercapnic respiratory failure with acidosis during initiation of oxygen therapy (ABG - pH less than 7.30 taken 2 - 4 hours after waking)
- •6. Unable to tolerate NIV (if given) during acute illness
- •7. Unstable coronary artery syndrome
- •8. Renal replacement therapy
- •9. Inability to consent/comply with trial protocol (as determined by site PI)
- •10. Aged less than 18 years
- •11. Pregnant
研究者
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